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K-ASSAY® Complement C4 Reagent

FDA UDI

Class II (US FDA UDI)

by Kamiya Biomedical Company, Llc

Identity

Trade Name
K-ASSAY® Complement C4 Reagent FDA UDI
Generic Name
Complement components C4/C4c IVD, reagent FDA UDI
Device Name
For the quantitative determination of human 4th complement component (Complement C4) in serum by immunoturbidimetric assay. FDA UDI
Model / Reference
KAI-010 FDA UDI
Description
For the quantitative determination of human 4th complement component (Complement C4) in serum by immunoturbidimetric assay. FDA UDI

Identifiers

Catalog Number
KAI-010 FDA UDI
Primary DI / UDI-DI
00816426020085 FDA UDI
510(k) Number
K993481 FDA UDI
FDA Product Code
DBI FDA UDI
GMDN Term
Complement components C4/C4c IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5240 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Complement components C4/C4c IVD, reagent

K-ASSAY® Complement C4 Reagent by Kamiya Biomedical Company, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Complement components C4/C4c IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kamiya Biomedical Company, Llc

Sources (1)

  • FDA UDI 251a4eb5-fc5d-4af4-9e07-61e6da38a783 37 fields · synced Jun 1, 2026